Tonix Pharmaceuticals Appoints Irina Ishak as General Counsel Amid Commercialization and Pipeline Expansion

Tonix Pharmaceuticals Holding Corp. has appointed Irina Ishak as General Counsel effective December 8, 2025, bringing extensive legal experience to the biotechnology company during a critical period of product commercialization and pipeline advancement. Ishak, who previously served as Senior Counsel at Lowenstein Sandler LLP where she advised Tonix on numerous legal matters, will now lead the company's legal, corporate governance and compliance functions internally. The appointment comes as Tonix commercializes TONMYA, the first FDA-approved fibromyalgia therapy in more than 15 years, which represents a significant milestone for the company and the millions of adults affected by this chronic pain condition.

CEO Seth Lederman emphasized that Ishak's corporate and transactional experience will be instrumental as the company executes its long-term strategy. Ishak expressed honor at joining Tonix during this pivotal period, having previously contributed to pharmaceutical development and launch efforts during her tenure at Savient Pharmaceuticals. Tonix's commercial portfolio extends beyond fibromyalgia treatment to include two acute migraine therapies: Zembrace SymTouch and Tosymra. The company's development pipeline spans multiple therapeutic areas, with investigational candidates addressing central nervous system disorders, immunology, immuno-oncology, rare diseases and infectious diseases.

One notable program is TNX-102 SL, which is being developed to treat acute stress reaction and acute stress disorder through an Investigator-Initiated IND at the University of North Carolina in the OASIS study funded by the U.S. Department of Defense. The company's immunology portfolio includes TNX-1500, a Phase 2-ready monoclonal antibody targeting CD40-ligand for preventing organ transplant rejection and treating autoimmune diseases. In rare diseases, TNX-2900 is being developed for Prader-Willi syndrome with a potential pivotal Phase 2 study expected in 2026.

Tonix's infectious disease programs feature TNX-801, a vaccine candidate for mpox and smallpox, and TNX-4800, a Phase 2-ready monoclonal antibody for seasonal prevention of Lyme disease. Additionally, TNX-4200 is being developed under a contract with the U.S. Department of Defense's Defense Threat Reduction Agency for up to $34 million over five years as a broad-spectrum antiviral agent targeting biological threats. Tonix operates a state-of-the-art infectious disease research facility in Frederick, Maryland, supporting its diverse development efforts. The company's latest corporate developments and updates are available through its newsroom at https://ibn.fm/TNXP. This leadership appointment strengthens Tonix's legal capabilities as it navigates the complex regulatory landscape of bringing multiple therapeutic candidates through development while managing commercial operations for its approved products.